Clinical Trial Associate (CTA) About Astellas: At Astellas, experience is coupled energised with a relentless challenger spirit. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation. We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers. We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients. The Opportunity: As the Clinical Trial Associate you will assist the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution, and close-out of assigned drug trials, which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). You will be accountable to the clinical trial team for the support of the trial execution and will work collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables. This position is based in the UK. Hybrid Working: At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.,
Responsibilities
* Supporting the day-to-day operations of assigned trials and responsibilities and ensuring completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
* Maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders.
* Participating in the development of core trial documents and trial level plans, as requested and/or leading on trial related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data.
* Contributing to the feasibility assessment and selection of countries and sites for trial conduct.
* Ensuring CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
* Clinical trial experience ideally within a sponsor setting.
* Strong knowledge of ICH/GCP guidelines and regulatory requirements as well as knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
* Participated in or facilitated site engagement and communications with investigators and/or staff to support trial milestones and deliverables
* Ensured quality and completeness of TMF for assigned clinical trials.
* Participated in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
* Supported in data cleaning and data review activities as requested.
Preferred Experience
* Project management skills and trial leadership ability.
Education
* Bachelor's Degree or equivalent.
Additional Information
* This is a permanent full-time position.
* This position is based in the UK.
* This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs.
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